Inspections, Compliance, Enforcement, and Criminal Investigations
Trilliant Surgical, LTD 5/3/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
4040 North Central Expressway
Dallas, Texas 75204-3128
May 3, 2010
RETURNED RECEIPT REQUESTED
Mr. John S. Olson, President
Trilliant Surgical, LTD
448 West 19th Street, Ste 366
Houston, Texas 77008
Dear Mr. Olson:
During an inspection of your firm located at 626 East 22nd Street, Houston, Texas 77008, on November 30, 2009, December 1 through 4, 2009, January 12, 15, and 20, 2010, an investigator from the United States Food and Drug Administration (FDA or Agency) determined that your company manufactures and distributes: (1) the Tiger Cannulated Screw Fixation System (screws) and accessories (screw drivers, drill bits, drill guides, guide wires, depth gauges, countersink, bone clamps, forceps, and screw removal tool) that are intended for fixation of fractures, non-unions, arthrodeses and osteotomies of the small bones in the hand and foot; and (2) the 3S Hemi Toe Implant that is designed to supplement first metatarsal phalangeal joint arthroplasty. Indications include hallux limitus or hallux rigidius, painful hallux valgus, revision of failed previous surgery and painful arthritis. Under section 201 (h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are medical devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
At the conclusion of the inspection, the investigator issued to you the Form FDA-483 (List of Inspectional Observations) which identifies a number of significant violations including, but not limited to, those described below. You verbally promised to the investigator that you will correct the inspectional observations in 90 days. As of May 3, 2010, we have not received your written response to the FDA 483.
Quality System Violations
1. Failure to adequately investigate the cause of nonconformities relating to product, processes, and the quality system, as required by 21 C.F.R. § 820.100(a)(2). FDA 483 Item 2. Specifically:
On or about March 9, 2009, your firm initiated (Corrective Action Request) CAR #001 and (Engineering Change Notice) ECN #1010 to implement a design change to the cannulated screw driver bits (Part # (b)(4) to address three complaints of product malfunction. Complaint 001 documented "the driver stem broke off during surgery." Complaint 002 documented "fragment of driver bit broke off during surgery." Complaint 004 documented "driver broke on final tightening." On March 19, 2009, your firm retrieved all driver bits of the previous design (Revision A) in commerce distribution from your distributors and replaced them with the redesigned driver bits (Revision B).
Your complaint file documented "the driver bit was damaged prior to use" or "the tip blades are susceptible to damage with light mishandling." Your CAR #001 and two subsequent addendums did not describe sufficient detail of user mishandling conditions before surgery that may have caused the driver bit to break during surgery, and explain why your mechanical test performed on July 23, 2008, did not detect impact fractures of the driver bits during simulated use conditions.
2. Failure to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished devices, as required by 21 C.F.R. § 820.100(a)(4), and failure to document the results of corrective and preventive action activities, as required by 21 C.F.R. § 820.100(b). FDA 483 Item 1. Specifically:
During the inspection, you added Addendum #2, dated January 14, 2010, to CAR #001 in order to include the test protocol of a simulated (b)(4) test of the redesigned driver bit. Your firm failed to maintain adequate documentation of the CAR in order to verify the effectiveness of the design change to the driver bit. For example:
a. Addendum #2 did not include the test results (data) of the simulated (b)(4) test. The addendum just provided a brief conclusion of the test results.
b. The simulated (b)(4) test protocol did not specify a statistical sample size of the tested driver bits, how many repeat (b)(4) tests were performed to detect impact fractures, simulated use conditions, and test equipment used.
c. The simulated (b)(4) test protocol and the conclusion of the test were not signed and dated by the person performing the test, did not document who performed the test, and when the test was performed.
3. Failure to establish and maintain adequate procedures for validating the device design in order to ensure that the devices conform to defined user needs and intended uses. The design validation must include testing of production units under actual or simulated use conditions, and risk analysis, where appropriate, and the design validation results must be documented, as required by 21 C.F.R. § 820.30(g). FDA 483 Item 5. Specifically:
a. Your design history file (Design Matrix) for the 3S Hemi Toe Implants does not document any risk analysis performed for the implant design and accessories (instruments used to implant the Hemi Toe Implants).
b. The (b)(4) testing documented in the mechanical test report, dated July 23, 2008, did not use your actual production driver bits Part (b)(4) of the cannulated screws for load testing. Instead, the (b)(4) testing used the (b)(4) driver bit from another manufacturer.
4. Failure to establish and maintain purchasing data that clearly describes or references the specified requirements, including quality requirements, for purchased or otherwise received product and services, as required by 21 C.F.R. § 820.50(b). FDA 483 Item 4. Specifically:
a. Your firm does not document a specification or requirement for (b)(4) of the cannulated screw driver (Part (b)(4) in your device master record or the drawing for this device accessory.
b. Your firm does not have documentation (SOPs, contract, or an agreement that defines the manufacturing responsibilities for your firm, (b)(4) that contract manufactures the cannulated screws and accessories, and (b)(4) that contract manufactures the 3S Hemi Toe Implants.
c. We noted that the certificate of analysis (COA) provided to you by (b)(4) did not always document the issuing date or the manufacturing date of each lot of the driver bits. See the COA for Item (b)(4) Revision B, Lot 0924081, Quantity of (b)(4) pieces.
5. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints to ensure that they, among other things, are processed in a uniform and timely manner and are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 C.F.R. § 803, as required by 21 C.F.R. §§ 820.198(a) and (d). Specifically:
Your firm has not obtained and documented information about potential medical adverse events for the three complaints of driver bits breaking during surgery received in February and March, 2009, and documented justification for not reporting these complaints as MDR reports to FDA. The investigator did not list this observation on the FDA 483 but discussed it with you during the inspection.
6. Failure to establish and maintain adequate procedures for quality audits, and failure to conduct such audits to assure that the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 C.F.R. § 820.22. FDA 483 Item 7. Specifically:
You have not conducted any quality audits of your firm's quality system since December 2008.
7. Failure to establish and maintain procedures for identifying training needs and to ensure that all personnel are trained to adequately perform their assigned responsibilities and that their training is documented, as required by 21 C.F.R. § 820.25(b). FDA 483 Item 6. Specifically:
Your Sales Training Procedure (SOP 17), effective dated December 1, 2009, and training presentation entitled "Customer Service Training Better than Brilliant" provided to your field sales representatives do not include an explanation of the complaint handling requirements set forth in 21 C.F.R. § 820.198 and how to obtain and report complaint information that may require MDR reporting by your firm, as required by C.F.R. § 803.
Reports of Corrections and Removals
Our inspection also revealed that your above-referenced devices are also misbranded under Section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed to furnish material or information respecting the devices that is required by or under Section 519(g)(1) of the Act, 21 U.S.C. § 360i(g)(1), and 21 C.F.R. § 806 - Reports of Corrections and Removals. Significant deviations include, but are not limited to, the following:
1. Failure to promptly report to FDA any correction and removal of a device to reduce a risk to health within 10 working days, as required by 21 C.F.R. § 806.1 0(a)(1). Specifically:
On or about March 9, 2009, your firm initiated a design change to the cannulated screw driver bits to address three complaints of driver bits breaking during surgery. On March 19, 2009, your firm retrieved all driver bits of the previous design in commerce distribution from your distributors and replaced them with the redesigned driver bits. Complaint #002 received on March 9, 2009, documented that the driver bit broke off during surgery, and the attending physician removed broken fragments from the foot. Complaint #001 received on February 6, 2009, documented that the physician was putting in the last implant screw when a prong of the driver stem broke off and that this left the screw
sticking up about 1 to 2 mm. Broken driver bits may result in a delay of surgery and medical intervention to locate and remove metal fragments from the surgical site. These conditions pose a risk to health. Your firm's action to retrieve the driver bits to prevent their further use meets the definition of a "removal" in 21 C.F.R. § 806.2(i), yet no report was submitted to FDA, in violation of 21 C.F.R. § 806.10(a)(1), which requires manufacturers or importers to submit a written report to FDA of any correction or removal of a device if the correction or removal was initiated to reduce a risk to health.
Responding to This Warning Letter
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in enforcement action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties.
Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, pre-market approval applications for Class III devices to which the Quality System regulation (21 CFR Part 820) deviations are reasonably related will not be approved until the violations have been corrected. Also, requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Thao Ta, Compliance Officer, Dallas District Office, Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the content of this letter, please contact Mr. Ta at 214-253-5217.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the FDA 483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality assurance systems.
You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Reynaldo R. Rodriguez, Jr.
Dallas District Director